Ranibizumab Biosimilar Program Updates

This week, three development programs announced updates to their ranibizumab biosimilars. Ranibizumab is the active ingredient in Genentech’s LUCENTIS, which is indicated for retinal vascular disorders, including neovascular (wet) age-related macular degeneration (AMD).

  • On June 25, 2021, Samsung Bioepis Co., Ltd. (“Samsung Bioepis”) and Biogen Inc. (“Biogen”) announced that the ranibizumab biosimilar candidate BYOOVIZ received a positive opinion from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP).  According to the press release, following CHMP’s positive opinion, BYOOVIZ will be referred to the European Commission to decide whether to grant a marketing authorization.  The positive CHMP opinion on BYOOVIZ was based on a Phase 3 clinical study that demonstrated equivalence in efficacy for both primary endpoints. Samsung Bioepis and Biogen announced in November 2019 that they had entered into a commercialization agreement for BYOOVIZ in the U.S., Canada, Europe, Japan and Australia. The Biologics License Application (BLA) for BYOOVIZ was accepted for review by the U.S. Food and Drug Administration (FDA) in November 2020.
  • On June 27, 2021, Xbrane Biopharma AB (“Xbrane”) announced that its ranibizumab biosimilar candidate XLUCANE met the primary endpoints in the 6 month interim read-out in its pivotal Phase III equivalence trial, XPLORE.  As we previously reported, Xbrane initiated the XPLORE trial in 2019 to study the biosimilarity of XLUCANE to LUCENTIS in wet AMD.  According to the press release, Xbrane plans to submit the Marketing Authorization Application (MAA) to the EMA in Q3 2021 and the BLA to the U.S. FDA in Q4 2021 on the basis of the interim results.
  • On June 28, 2021, Teva Pharmaceutical Industries Ltd. (“Teva”) and Bioeq AG (“Bioeq”) announced that they entered into a strategic partnership for the exclusive commercialization of Bioeq’s ranibizumab biosimilar candidate, FYB201, in Europe, Canada, Israel and New Zealand.  According to the press release, Bioeq will be responsible for the development, registration, and supply of the biosimilar, while Teva will be responsible for commercializing the product.  As we previously reported, Coherus BioSciences, Inc. (“Coherus”) and Bioeq entered into a commercialization agreement to market and distribute FYB201 in the United States.

Stay tuned to Big Molecule Watch for further biosimilar development updates.